EBIClass II
Resin, Denture, Relining, Repairing, Rebasing
21 CFR 872.3760 / Dental
EBI is the FDA product code for Resin, Denture, Relining, Repairing, Rebasing, a class II device type, regulated under 21 CFR 872.3760. As of , FDA records hold 335 510(k) clearances under this code, the most recent dated , and 16 recalls.
Classification record
- Product code
- EBI
- Device name
- Resin, Denture, Relining, Repairing, Rebasing
- Regulation
- 21 CFR 872.3760
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 335
- Ingested recalls
- 16
Clearances, product code EBI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 5 |
| 1981 | 3 |
| 1982 | 3 |
| 1983 | 4 |
| 1984 | 8 |
| 1985 | 2 |
| 1986 | 4 |
| 1987 | 13 |
| 1988 | 3 |
| 1989 | 8 |
| 1990 | 11 |
| 1991 | 8 |
| 1992 | 6 |
| 1993 | 5 |
| 1994 | 7 |
| 1995 | 11 |
| 1996 | 8 |
| 1997 | 4 |
| 1998 | 13 |
| 1999 | 20 |
| 2000 | 5 |
| 2001 | 10 |
| 2002 | 6 |
| 2003 | 8 |
| 2004 | 5 |
| 2005 | 5 |
| 2006 | 7 |
| 2007 | 10 |
| 2008 | 6 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 11 |
| 2012 | 3 |
| 2013 | 5 |
| 2014 | 5 |
| 2015 | 9 |
| 2016 | 7 |
| 2017 | 8 |
| 2018 | 5 |
| 2019 | 4 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 11 |
| 2023 | 11 |
| 2024 | 9 |
| 2025 | 11 |
| 2026 | 7 |
Applicants with the most clearances
Product code EBI| Applicant | Clearances |
|---|---|
| Dentsply Intl. | 16 |
| Kulzer GmbH | 16 |
| GC America Inc. | 12 |
| Harry J. Bosworth Co. | 8 |
| Lang Dental Mfg Co, Inc. | 7 |
| Vertex-Dental B.V. | 7 |
| Dentsply Sirona Inc | 6 |
| Stick Tech Ltd. | 6 |
| Voco GmbH | 6 |
| Austenal Dental, Inc. | 5 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.